PMID- 29703690
OWN - NLM
STAT- MEDLINE
DCOM- 20190919
LR  - 20190919
IS  - 1938-0666 (Electronic)
IS  - 1526-8209 (Linking)
VI  - 18
IP  - 5
DP  - 2018 Oct
TI  - Quality-Adjusted Survival With nab-Paclitaxel Versus Standard Paclitaxel in 
      Metastatic Breast Cancer: A Q-TWiST Analysis.
PG  - e919-e926
LID - S1526-8209(17)30778-4 [pii]
LID - 10.1016/j.clbc.2018.03.014 [doi]
AB  - BACKGROUND: In this analysis we compared quality-adjusted survival outcomes 
      between nab-paclitaxel (nab-P) and standard paclitaxel (Pac) using data from the 
      nab-P phase III registration trial in metastatic breast cancer. PATIENTS AND 
      METHODS: Quality-adjusted overall survival was estimated using the 
      quality-adjusted time without symptoms or toxicity (Q-TWiST) approach. Overall 
      survival was partitioned into time without progression/Grade >/= 3 adverse events 
      (AEs) toxicity (TWiST), time with Grade >/= 3 AE toxicity (TOX), and time after 
      relapse (REL). Q-TWiST was calculated by multiplying mean time in each health 
      state by its assigned utility (base-case utility values: time without symptoms of 
      disease progression or toxicity of Grade >/= 3 adverse events [TWiST] = 1.0, TOX = 
      0.5, and REL = 0.5). In threshold analyses, TOX and REL varied from 0.0 to 1.0 
      whereas TWiST was maintained at 1.0. Comparisons were made for the 
      intent-to-treat population and the subset of patients initiating the study drugs 
      as second or subsequent lines (2L+) of chemotherapy (per approved nab-P 
      indication; 2L+ subpopulation). A >/= 15% relative Q-TWiST gain (vs. mean Pac 
      overall survival) was considered clearly clinically important. RESULTS: In the 
      intent-to-treat population, nab-P (n = 229) versus Pac (n = 225) resulted in 
      nonsignificant gains of 1.4 months of mean Q-TWiST (11.6 vs. 10.2 months; 95% 
      confidence interval [CI], -0.03 to 2.8). In the 2L+ subpopulation, nab-P (n = 
      132) versus Pac (n = 136) resulted in a statistically significant gain of 2.2 
      months of mean Q-TWiST (10.5 vs. 8.4 months; 95% CI, 0.6-3.8), with a 17.1% 
      relative Q-TWiST gain (threshold analysis range, 14.0%-19.5%, both figures 
      significant). CONCLUSION: In its approved indication for metastatic breast 
      cancer, nab-P showed a statistically significant and clearly clinically important 
      improvement in quality-adjusted survival time versus Pac in the 2L+ 
      subpopulation.
CI  - Copyright (c) 2018 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Cortes, Javier
AU  - Cortes J
AD  - University Hospital Ramon y Cajal, Madrid, Spain; Vall d'Hebron Institute of 
      Oncology, Barcelona, Spain. Electronic address: jacortes@vhio.net.
FAU - Perez-Garcia, Jose
AU  - Perez-Garcia J
AD  - Baselga Institute of Oncology, Hospital Quiron, Barcelona, Spain.
FAU - Whiting, Scott
AU  - Whiting S
AD  - The Queen's Medical Center, Honolulu, HI.
FAU - Wan, Yin
AU  - Wan Y
AD  - Pharmerit International, Bethesda, MD.
FAU - Solem, Caitlyn
AU  - Solem C
AD  - Pharmerit International, Bethesda, MD.
FAU - Tai, Ming-Hui
AU  - Tai MH
AD  - Pharmerit International, Bethesda, MD.
FAU - Margunato-Debay, Sandra
AU  - Margunato-Debay S
AD  - Celgene Corporation, Summit, NJ.
FAU - Ko, Amy
AU  - Ko A
AD  - Celgene Corporation, Summit, NJ.
FAU - Fandi, Abderrahim
AU  - Fandi A
AD  - Celgene Corporation, Summit, NJ.
FAU - Botteman, Marc
AU  - Botteman M
AD  - Pharmerit International, Bethesda, MD.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20180330
PL  - United States
TA  - Clin Breast Cancer
JT  - Clinical breast cancer
JID - 100898731
RN  - 0 (130-nm albumin-bound paclitaxel)
RN  - 0 (Albumins)
RN  - 0 (Antineoplastic Agents, Phytogenic)
RN  - P88XT4IS4D (Paclitaxel)
SB  - IM
MH  - Albumins/adverse effects/*therapeutic use
MH  - Antineoplastic Agents, Phytogenic/adverse effects/*therapeutic use
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - Breast Neoplasms/*drug therapy/*pathology
MH  - Clinical Trials, Phase III as Topic
MH  - Female
MH  - Humans
MH  - Middle Aged
MH  - Neoplasm Metastasis
MH  - Paclitaxel/adverse effects/*therapeutic use
MH  - Quality of Life
MH  - Survival Analysis
OTO - NOTNLM
OT  - Chemotherapy
OT  - Metastatic breast cancer
OT  - Quality-adjusted time without symptoms of disease progression or toxicity of 
      treatment
OT  - Taxanes
OT  - nab-Paclitaxel
EDAT- 2018/04/29 06:00
MHDA- 2019/09/20 06:00
CRDT- 2018/04/29 06:00
PHST- 2017/12/04 00:00 [received]
PHST- 2018/02/23 00:00 [revised]
PHST- 2018/03/26 00:00 [accepted]
PHST- 2018/04/29 06:00 [pubmed]
PHST- 2019/09/20 06:00 [medline]
PHST- 2018/04/29 06:00 [entrez]
AID - S1526-8209(17)30778-4 [pii]
AID - 10.1016/j.clbc.2018.03.014 [doi]
PST - ppublish
SO  - Clin Breast Cancer. 2018 Oct;18(5):e919-e926. doi: 10.1016/j.clbc.2018.03.014. 
      Epub 2018 Mar 30.